Preliminary Results of Betaseron(R) 16 Year Study

[jeffs]

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Preliminary Results of Betaseron(R) Sixteen-Year Long-Term Follow-up Study Suggest Positive Long-Term Impact of Early Treatment Initiation
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MIAMI, April 14 /PRNewswire/ -- Preliminary results of the first 16-year,
long-term follow-up study of patients with multiple sclerosis (MS) from the
Betaseron(R) (interferon beta-1b) pivotal trial show that treatment with
Betaseron is safe in the long-term. Data presented today at the American
Academy of Neurology meeting are the longest-term assessment of any MS-
specific treatment carried out to date.
The Betaseron 16-Year Long-Term Follow-up Study (16-LTF) provides clinical
assessment of patients who first enrolled in the Betaseron pivotal trial
between 1988 and 1990. Study investigators started reaching out to patients
from the original Betaseron pivotal trial in January 2005. To date, 234
patients have been identified (63 percent of the original cohort). All 11
original trial sites are participating in the study, and some sites have
identified all of their original patients. The percentage of patients
identified at this point in the analysis is identical for all original
treatment groups. The Betaseron 16-Year Long-Term Follow-up Study is expected
to be completed later this year.
The results of the Betaseron pivotal trial led to the U.S. approval of
Betaseron 250 mcg for the treatment of relapsing-remitting MS. In the
original pivotal trial, patients were placed in one of three study arms:
Betaseron 50 mcg, Betaseron 250 mcg or placebo. The Betaseron 50 mcg dose was
a study dose only, and was found to be a non-effective dose.
Focusing on the preliminary assessment of the study arm for the currently
marketed dose of Betaseron 250 mcg compared to placebo*, the results reveal
that:

-- To date, patients treated with Betaseron 250 mcg in the pivotal trial
are more likely to report continued ability to walk unaided or using
aids. Thirty-nine of the 78 patients (50 percent) originally assigned
to the Betaseron 250 mcg group reported being able to walk with or
without assistance, compared with 32 of the 78 patients (41 percent)
originally assigned to the placebo group.

-- Nearly 90 percent of the 234 patients identified to date are still
alive. Seventy-three of the 78 identified patients (94 percent)
originally assigned to the Betaseron 250 mcg group are still alive,
compared with 64 of the 78 identified patients (82 percent) originally
assigned to the placebo group.

"The differences between the original treatments groups in the preliminary
data warrant further investigation. It is important to determine if the
treatment benefits seen in the first years of the Betaseron pivotal trial
confer long-term benefits, as these preliminary results might suggest," said
Professor George Ebers, lead investigator of the Betaseron 16-LTF Study,
Action Research Professor, University Department of Clinical Neurology,
Oxford, UK. "This is the first study to look at the impact of treating
patients with disease-modifying interferons on hard, unequivocal endpoints
such as long-term disability and life expectancy. In general, multiple
sclerosis does not substantially reduce life expectancy, but numerous studies
have demonstrated a modest, yet clear, reduction in untreated patients.
"We are making a concerted effort to track as many original patients as
possible for the study," continued Professor Ebers. "I anticipate that the
full study results will help us to better judge the question of long-term
effectiveness. In addition, the full results will provide us with data we do
not have at this preliminary stage around the measurement of cognitive
function including memory, attention, and reasoning. This type of information
is very important to patients and their families.
"Betaseron has been an important part of my practice for treating MS
patients since it was approved in 1993. As one of the original trial
investigators on the pivotal trial, it is gratifying to take part in the
continuing long-term research of its safety, efficacy and tolerability," said
Barry Arnason, MD, Professor, Department of Neurology, University of Chicago.
"While it is premature to draw firm conclusions from preliminary data, I am
particularly struck by the mortality trend among patients in the placebo arm
appearing to be three-fold different than that of patients receiving
Betaseron. The reasons for this difference are unknown right now, but
hopefully, we will get a clearer understanding of why this difference occurred
when the study is completed and the data analyzed more fully."

Sixteen Years of Betaseron Trials in Patients with MS
The Betaseron pivotal trial was the first large, randomized, placebo-
controlled study of any therapy in MS. This groundbreaking study was
conducted in North America and led to the approval of Betaseron, the first
disease-modifying agent for MS, in 1993. Patients were placed in one of three
study arms, Betaseron 50 mcg, Betaseron 250 mcg or placebo, with a median
duration of 45-48 months. Analysis after two years demonstrated that
significantly more patients receiving Betaseron were relapse-free, that those
relapses that occurred were less severe, and that hospitalizations for MS were
cut nearly in half. These results were again demonstrated at five years.
At the 12-year mark, the pioneering Betaseron clinical trial program again
reported positive efficacy and safety results. The London (Ontario) MS clinic
conducted a follow-up study with the 45 patients from the clinic who
participated in the pivotal trial. This 12-year study -- the longest follow-
up study of its kind, at that time -- demonstrated the long-term efficacy and
safety of Betaseron.
Now, the Betaseron 16-LTF Study is expected to provide landmark long-term
effectiveness and safety data for patients initiated on Betaseron compared to
control populations. Moreover, the results are expected to elucidate possible
effects of early treatment initiation on a patient's clinical disease course.
"We anticipate that the key findings of the 16-Year Long-Term Follow-up
Study will add to the level of confidence that physicians and patients have
come to expect from Betaseron, and build upon its proven safety, efficacy and
tolerability track record," said Ralph Makar, Vice President and General
Manager, Therapeutics Business Unit, Berlex Laboratories. "From pioneering
therapeutic breakthroughs to establishing first-in-class patient support
programs, Berlex has always been committed to helping people with MS learn to
manage their disease and live as normal a life as possible."

(*) In the preliminary data collected to date, the results for the
Betaseron 50 mcg dose were variable. Depending on the end point, the
results were similar to either the Betaseron 250 mcg dose or placebo.

ABOUT BETASERON
Betaseron was the first therapy approved in the United States to treat
relapsing-remitting MS, the most common form of the disease. Tens of
thousands of patients worldwide have used Betaseron in controlled research
studies and in clinical practice, providing the broadest experience of any MS
therapy. More than a decade after its introduction, Betaseron continues to be
a first-line agent for relapsing forms of MS.
Chiron Corporation and Berlex, Inc., jointly developed Betaseron. It is
manufactured by Chiron and sold in the United States by Berlex.
Betaseron is indicated for the treatment of relapsing forms of MS to
reduce the frequency of clinical exacerbations. Relapses are repeat attacks
during which new symptoms appear or existing symptoms worsen, followed by
periods of recovery. Relapsing forms of MS include relapsing-remitting, the
most common form, and secondary progressive MS with relapses.
In January 2002, the FDA approved a room-temperature-stable formulation of
Betaseron. Betaseron is the first and only interferon beta therapy available
in the United States that is stable at room temperature (250C/770F) for more
than 30 days, providing a convenient option for MS patients. Injections for
this formulation should be administered immediately after preparation. If the
injection is delayed, the solution should be refrigerated and injected within
a three-hour time period.
The recommended dose of Betaseron (interferon beta-1b) is 250 mcg injected
subcutaneously every other day, which delivers an average total of 875 mcg per
week.
The most commonly reported adverse reactions are lymphopenia, injection
site reaction, asthenia, flu-like symptom complex, headache and pain.
Betaseron should be used with caution in patients with depression. Injection
site necrosis has been reported in five percent of patients in controlled
trials. Patients should be advised of the importance of rotating injection
sites. Female patients should be cautioned about the potential risk of
pregnancy. Cases of anaphylaxis have been reported rarely. (See "Warnings,"
"Precautions," and "Adverse Reactions" sections of Prescribing Information).
For full prescribing information, please visit www.betaseron.com.




SOURCE Berlex, Inc.

[Granny BJ Betty]

Schering completes recruitment for its multiple sclerosis BEYOND trial
07.20.2005, 09:56 AM
Forbes – USA


BERLIN (AFX) - Schering AG said it has completed recruitment for its multiple sclerosis trial BEYOND from which final results are expected in 2007.

This study is the largest ever, randomized, blinded, clinical multiple sclerosis study, and it will examine the efficacy of a higher dosage of the company's breadwinner, Betaferon (Betaseron) to treat multiple sclerosis.

Betaferon 250 mcg has been on the market for 16 years, and this new trial will evaluate whether 2100 patients with relapsing-remitting multiple sclerosis (RRMS) derive greater benefit from a 500 mcg dose, which is also higher than that of any currently available interferon (a protein which fights virus multiplication in cells).

Additionally, the BEYOND study will compare the efficacy of Betaferon with glatiramer acetate (a non-interferon) in patients with RRMS.

'The BEYOND study is expected to show that the BEYOND dose of Betaferon is more efficacious than any currently available interferon,' said head of specialized therapeutics at Schering, Joachim-Friedrich Kapp.

Results from the first phase of the BEYOND program, published in Sep, 2003, showed the dosage was safe and well tolerated.

The Berlin-based pharmaceutical recently released preliminary results from a 16-year study of the MS drug.

This showed a positive long-term impact on patients.

This trial, to be completed later this year, is expected to clarify possible effects of early treatment initiation on a patient's clinical disease course, Schering added.

Betaferon sales reached 780 mln eur in 2004